DICLOFENAC KERN PHARMA 11.6 mg/g GEL

2. What you need to know before starting to use Diclofenac Kern Pharma

Do not use Diclofenac Kern Pharma

• if you are allergic to diclofenac or any of the other components of this medication (listed in section 6),
• (also used to prevent blood clotting). If you are unsure, consult your doctor or pharmacist,
• if you are in the last 3 months of pregnancy
• if you are under 14 years old,
• do not apply to wounds, eczematous lesions, mucous membranes, or burns.

If you think you may be allergic, consult your doctor.

Warnings and precautions

• Do not apply to areas of the skin where there are open cuts or wounds, or to mucous membranes, or over eczema or areas of the skin with a skin rash.
• Avoid contact of Diclofenac Kern Pharma with the eyes. If this happens, rinse your eyes with clean water. Consult your doctor or pharmacist if you feel any discomfort afterwards.
• Do not use occlusive dressings.
• Do not use on large areas. Use exclusively on the affected area.
• Do not apply Diclofenac Kern Pharma simultaneously to the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. Diclofenac Kern Pharma is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
• The treated areas should not be exposed to the sun (even if cloudy) or to ultraviolet radiation lamps (UVA rays).

Consult your doctor or pharmacist before starting to use Diclofenac Kern Pharma.

Children and adolescents

This medication is not recommended for use in children and adolescents under 14 years old, as there is not enough data available on safety and efficacy.

Use in elderly patients

Diclofenac Kern Pharma can be used in patients over 65 years old.

Use of Diclofenac Kern Pharma with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Diclofenac Kern Pharma should not be used if you are in the last 3 months of pregnancy. Do not use Diclofenac Kern Pharma during the first 6 months of pregnancy, unless it is strictly necessary and recommended by your doctor. If you need treatment during this period, you should take the minimum possible dose for the shortest possible time. Oral formulations (e.g., tablets) of diclofenac may cause adverse reactions to the fetus. It is unknown whether this same risk applies to Diclofenac Kern Pharma when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

During breastfeeding, do not use Diclofenac Kern Pharma, unless your doctor has indicated it.

It should never be applied directly to the breast area.

Driving and using machines

No effects on the ability to drive vehicles or use machinery have been described when used externally on the skin.

Diclofenac Kern Pharma contains propylene glycol (E-1520)

This medication contains 50 mg of propylene glycol per gram of gel.

3. How to use Diclofenac Kern Pharma

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

This medication is for application to the skin (cutaneous use).

The recommended dose is:

Adults and adolescents over 14 years old

Apply 3 or 4 times a day a small amount of gel to the inflamed or painful area.

The amount of gel will vary depending on the size of the affected area (normally, it will be sufficient to apply an amount similar to the size of a cherry or a walnut).

Use in children and adolescents under 14 years old

This medication is not recommended for use in children and adolescents under 14 years old, as there is not enough data available on safety and efficacy.

Mode of use:

• For the first use of the tube, unscrew the cap. Insert the back of the cap into the piece that closes the tube. Turn the cap until the tube is open.
• Spread a thin layer of the gel over the area of the skin where there is pain and inflammation, using a gentle massage.
• Close the tube well after use.
• Wash your hands after applying the gel.

If the pain or swelling worsens or persists after 7 days of treatment, consult your doctor.

If you use more Diclofenac Kern Pharma than you should

If you accidentally ingest Diclofenac Kern Pharma or if you have used it on a large area of skin and for a long period, adverse reactions similar to those produced by diclofenac when taken orally (e.g., tablets) may occur.

The main symptoms of overdose are: gastrointestinal or kidney disorders and difficulty breathing, nausea, vomiting, abdominal pain, and decreased level of consciousness may occur.

If you have applied too much of the medication, it is recommended to remove it by washing the affected area with plenty of water, or by removing some of it.

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Diclofenac Kern Pharma

If you forgot to apply this medication when it was due, apply the gel as soon as possible and continue the treatment normally.

Do not apply a double dose to make up for forgotten doses.

If you interrupt treatment with Diclofenac Kern Pharma

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Some rare and very rare side effects can be serious.

If you experience any of the following signs of allergy, stop using Diclofenac Kern Pharma and consult your doctor or pharmacist immediately:

• Rare (may affect between 1 and 10 out of 10,000 patients): Skin rash with blisters; urticaria (red, raised, and often itchy and burning rashes).
• Very rare (may affect less than 1 in 10,000 patients): Difficulty breathing or feeling of pressure in the chest (asthma); swelling in the face, lips, tongue, or throat.

Non-serious side effects:

Other side effects may occur, but they are usually mild and temporary. If you notice any of them, consult your doctor or pharmacist as soon as possible.

• Frequent (may affect between 1 and 10 out of 100 patients): Rash, itching, redness, or burning sensation on the skin after using the product.
• Very rare (may affect less than 1 in 10,000 patients): The skin may be more sensitive to the sun (photosensitivity). The signs are: sunburn with itching, swelling, and blisters.
• Frequency not known (cannot be estimated from available data): Burning sensation at the application site, dry skin.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Diclofenac Kern Pharma

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Once opened, discard the tube with the remaining gel after 12 months.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Diclofenac Kern Pharma 11.6 mg/g

• The active ingredient is diclofenac diethylamine. Each gram of gel contains 11.6 mg of diclofenac diethylamine (which corresponds to 10 mg of diclofenac sodium).
• The other components (excipients) are: propylene glycol (E-1520), isopropanol, diethylamine, liquid paraffin, polyoxyethylene alkyl ether, carbomer 934P NF, coco-caprylate/caprate, perfume cream 1876601, purified water.

Appearance of the product and package contents

Diclofenac Kern Pharma 11.6 mg/g gel is a viscous and white gel. It is packaged in an aluminum tube with a screw cap.

The medication is available in tubes with 60 and 100 grams of gel.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet:May 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.